Active — Not RecruitingNot Applicable

A Study to Investigate the Effect of a Meal At 6pm the Day Before the Colonoscopy on the Bowel Cleansing with Plenvu

Belgium525 participantsStarted 2023-02-14

Plain-language summary

Bowel cleansing prior to colonoscopy is crucial to be able to perform a high-quality examination. Therefore maximum efforts are made to achieve optimal bowel cleansing including diet restriction and refraining from day-before dinner. However, the effect of this interdiction is currently not clear. On the other hand, patient compliance and experience with the entire procedure is important, especially for follow-up colonoscopies. Strict diets may interfere with this as an additional burden on the patient. In this study we want to assess whether a more lenient diet influences the quality of bowel preparation and whether it improves patient's experience.

Who can participate

Age range40 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient referred for diagnostic colonoscopy * Age between 40 and 85 years old * Ability of normal oral ingestion * Able to give informed consent by the patient or the legal representative Exclusion Criteria: * Participant has a history of (partial) colectomy, excluding appendectomy * Inability of oral ingestion * Chronic severe constipation, defined as the need for daily laxative use of any kind or the need to use laxatives to obtain defaecation. * Uncontrolled coagulopathy * Pregnancy * Premenopausal women not adhering to any contraceptive method * Inflammatory bowel disease * Lynch syndrome * Familial adenomatosis polyposis syndrome * Serrated polyposis syndrome * hypersensitivity to the active substances of PLENVU as listed in the SmPC section 6.1 * gastrointestinal obstruction or perforation * ileus * gastric emptying disorders (e.g. gastroparesis, gastric retention, etc.) * phenylketonuria (due to the presence of aspartame in PLENVU) * glucose-6-phosphate dehydrogenase deficiency (due to the presence of ascorbate in PLENVU) * toxic megacolon * Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol * Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial

What they're measuring

Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)

Timeframe: Max 12 weeks

Trial details

NCT IDNCT06651398

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11